Endura™ Ureteral Stent and Stent Set

The Endura™ Ureteral Stent and Stent Set is a flexible tubular device made of thermoplastic polyurethane with self-retaining coiled pigtail structures at both ends, designed to relieve urinary obstruction in benign, malignant, and post-traumatic ureteral conditions. It is placed using endoscopic or percutaneous radiographic techniques with a recommended maximum indwelling time of 365 days and is not intended as a permanent device.

The proposed device features a double-pigtail design with drainage holes, is available in sizes 4.5Fr to 10Fr and lengths 18cm to 30cm, is made of thermoplastic polyurethane, and is provided as a single-use EtO-sterilized device. The predicate device (Bard® InLay Optima™) has a similar double-pigtail design but includes a distal suture thread and is available in fewer size options (4.7Fr to 8Fr, 14-30cm lengths).

Testing followed FDA Guidance for Ureteral Stents (February 1993) and included ASTM F1828-22 for radiopacity, elongation, tensile strength and curl strength; ASTM F623-19 for flow rate; ISO 11135:2014+A1:2018 for EtO sterilization validation; ASTM D4169-22 and F1980-21 for packaging and shelf-life; and ISO 10993-1 for biocompatibility including cytotoxicity, sensitization, irritation, acute toxicity, pyrogen, implantation, and chemical extractables analysis.

The Endura™ Ureteral Stent is substantially equivalent to the Bard® InLay Optima™ predicate because both devices share identical indications for use, the same regulatory classification (Class II, 21 CFR 876.4620), equivalent technological characteristics (double-pigtail design, thermoplastic polyurethane material, single-use EtO sterilization), and all non-clinical performance testing meets defined acceptance criteria demonstrating appropriate performance for intended use.